Sensored surgical tool and surgical intraoperative tracking and imaging system incorporating same

ABSTRACT

Described are various embodiments of a sensored surgical tool, and surgical intraoperative tracking and imaging system incorporating same. In one embodiment, the surgical tool comprises a rigid elongate tool body having a substantially rigid tool tip to be displaced and tracked within the surgical cavity so to reproducibly locate the tool tip within the cavity. The tool further comprises one or more tool tip cameras and/or pressure sensors operatively disposed along the body at or proximal to the tool tip.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of Canadian Patent Application No.2,957,977, filed Feb. 15, 2017, which is incorporated herein byreference in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to surgical instruments, tools andsystems, and, in particular, to a sensored surgical tool for use, forexample, within a surgical cavity, such as an open port-based orvisually accessible surgical cavity, and a surgical system incorporatingsuch tool, such as a surgical intraoperative tracking and imagingsystem.

BACKGROUND

Various surgical site imaging techniques and tools have been developedto improve the accuracy and ultimate success of a given surgicalprocedure. Known imaging tools for visually closed-access surgicalprocedures, for example those channeled through an anatomical lumen(e.g., vascular, intestinal procedures), may include fiber optic scopes,optical coherence tomography (OCT) probes, micro ultrasound transducersand the like, wherein a generally flexible tool is inserted andchanneled to a surgical site of interest.

Visually open-access surgical sites, for example, those employing asurgical access port or the like, generally rely on external imagingdevices, such as an overhead down-cavity surgical microscope or anexternal videoscope and display system. Accordingly, surgical siteimaging is generally limited to the different fields of view and viewangles available to the external scope and/or surgical microscope whichnot only generally limits visibility to down-port images, but is alsosubject to visibility issues when blood or other fluids immerse thesurgical cavity or port bottom. Given the limited working space withinthe port/cavity, and, particularly, for neurosurgical applications, thehighly critical nature of any down-port maneuvers and/or tissueinteractions, limited visibility can result in significant surgicalchallenges, particularly, for example, when seeking to blindly locateand address a bleeding site or evaluate externally visually inaccessibleareas within the cavity, such as areas blocked by visually interferingtissue.

Currently, a surgeon will generally seek to reduce the volume ofvisually interfering fluids using a suction tool in an attempt toidentify and address a bleeding/leaking site, for example, before thecavity/port is re-immersed with fluid. As for gaining visibility aroundor below visually interfering tissue, the surgeon may rather seek tore-angle the external scope or microscope, albeit within field of viewand view angle limits prescribed by the external equipment and surgicalcavity/port. Accordingly, significant challenges remain in adequatelyvisualizing, characterizing and addressing visually inaccessible,obscured or obstructed portions of the surgical cavity.

This background information is provided to reveal information believedby the applicant to be of possible relevance. No admission isnecessarily intended, nor should be construed, that any of the precedinginformation constitutes prior art or forms part of the general commonknowledge in the relevant art.

SUMMARY

The following presents a simplified summary of the general inventiveconcept(s) described herein to provide a basic understanding of someaspects of the disclosure. This summary is not an extensive overview ofthe disclosure. It is not intended to restrict key or critical elementsof embodiments of the disclosure or to delineate their scope beyond thatwhich is explicitly or implicitly described by the following descriptionand claims.

A need exists for a sensored surgical tool, and surgical systemincorporating same, that overcome some of the drawbacks of knowntechniques, or at least, provides a useful alternative thereto. Someaspects of this disclosure provide examples of such tools and systems.

For instance, in accordance with some aspects of the present disclosure,a sensored surgical tool is described for use in a surgical cavity toprovide increased intraoperative inner-cavity visibility andcharacterization to supplement external imaging device capabilities, forexample, to access, image and/or characterize obscured, obstructed orotherwise externally visually inaccessible regions of the surgicalcavity. In some aspects, such enhanced inner-cavity characterization mayimprove intraoperative imaging of the cavity while also assisting inlocating and addressing inner-cavity bleeding or other fluid immersions,for example, by location-tracking and mapping imaging andcharacterization capabilities of the herein-described tools and systems.

In accordance with one aspect, there is provided a surgical tool for usewithin a surgical cavity, the surgical tool comprising: a rigid elongatetool body having a substantially rigid tool tip to be displaced andtracked within the surgical cavity so to reproducibly locate said tooltip within the cavity; and a pressure sensor operatively disposed alongsaid body at or proximal to said tool tip and responsive to pressurevariations applied thereto from within the surgical cavity to output asensor signal representative thereof as the tool is displaced within thecavity, wherein said sensor signal is externally communicable toassociate respective inner-cavity pressure readings with tracked tooltip locations.

In one embodiment, the pressure sensor is laterally oriented relative tosaid tip.

In one embodiment, the surgical tool further comprises two or more saidpressure sensor at or proximate said tool tip.

In one embodiment, the surgical tool further comprises a set of fiducialmarkers externally coupled in a fixed configuration to an externallyextending portion of said elongate body, wherein said markers aretrackable by an external tracking system to automatically determine saidtracked tool tip locations with reference to the cavity based on arespective tracked position of said markers.

In one embodiment, the surgical tool further comprises a radio frequencytransmitter to wirelessly communicate said sensor signal.

In one embodiment, the pressure sensor comprises two or more pressuresensors collocated at or toward said tool tip.

In one embodiment, the surgical tool further comprises a suction tool ator proximal to said tip to concurrently provide suction within thesurgical cavity around said tip.

In one embodiment, the surgical cavity is externally visible to anexternal camera aligned therewith, and wherein said tip is operable as atrackable pointer within the cavity.

In one embodiment, the surgical tool further comprises at least onecamera disposed and laterally-oriented along said body at or proximal tosaid tip so to capture lateral images from within the surgical cavity,wherein said lateral images are externally communicable to associaterespective inner-cavity images with tracked tool tip locations.

In one embodiment, the surgical tool further comprises at least onecomplementary camera disposed along said body at or proximal to said tipso to capture complementary images of the surgical cavity along acomplementary imaging axis angled downwardly relative to saidlaterally-oriented camera so to construct a 3D inner-cavity mapping oran enlarged field of view image of the surgical cavity from said lateralimages and said complementary images.

In one embodiment, the surgical cavity is visibly accessible to anexternal camera or scope aligned therewith, and wherein saidinner-cavity images are complementary to external images captured bysaid external camera or scope in enhancing inner-cavity visualization.

In one embodiment, the tip is movable within the cavity to trackpressure variations resulting from inner-cavity bleeding in locating ableeding site within the cavity.

In one embodiment, the tool body comprises a reusable tool shaft portionand a disposable tool tip portion removably operatively connectable tosaid shaft portion, wherein said tip portion comprises said tip and saidpressure sensor.

In accordance with another aspect, there is provided a surgical systemfor performing surgery through an externally accessible surgical cavity,the system comprising: a surgical tool comprising: a rigid elongate toolbody having a substantially rigid tool tip to be displaced and trackedwithin the surgical cavity so to reproducibly locate said tool tipwithin the cavity; and a pressure sensor operatively disposed along saidbody at or proximal to said tool tip and responsive to pressurevariations applied thereto from within the surgical cavity to output asensor signal representative thereof as the tool is displaced within thecavity; an external tracking system operatively interfacing with saidsurgical tool to automatically track a location of said tool tip withinthe cavity; and an external data processing unit operable to associate agiven pressure reading associated with said sensor signal with acorresponding location of said pressure sensor within the cavity.

In one embodiment, the system further comprises a set of fiducialmarkers externally coupled in a fixed configuration to an externallyextending portion of said elongate body, and wherein said markers aretrackable by an external surgical navigation system to automaticallyassociate said corresponding location of said pressure sensor within thecavity based on a respectively tracked position of said markers.

In one embodiment, the pressure sensor is laterally oriented relative tosaid tip.

In accordance with another aspect, there is provided a surgical tool foruse within a surgical cavity, the surgical tool comprising: a rigidelongate tool body having a substantially rigid tool tip to be displacedand tracked within the surgical cavity so to reproducibly locate saidtool tip within the cavity; and at least one laterally-oriented cameraoperatively disposed along said body at or proximal to said tip so tocapture lateral inner-cavity images of the surgical cavity for output asthe tool is displaced within the cavity, wherein said lateralinner-cavity images are externally communicable to associate respectivelateral inner-cavity images with tracked tool tip locations.

In one embodiment, the surgical tool further comprises a set of fiducialmarkers externally coupled in a fixed configuration to an externallyextending portion of said elongate body, wherein said markers aretrackable by an external tracking system to automatically determine saidtracked tool tip locations with reference to the cavity based on arespective tracked position of said markers.

In one embodiment, the surgical tool further comprises a radio frequencytransmitter to wirelessly communicate said lateral inner-cavity images.

In one embodiment, the surgical tool further comprises a suction tool ator proximal to said tip to concurrently provide suction within thesurgical cavity around said tip.

In one embodiment, the surgical tool further comprises at least onecomplementary camera disposed along said body at or proximal to said tipso to capture complementary images of the surgical cavity along acomplementary imaging axis angled downwardly relative to saidlaterally-oriented camera so to construct a 3D inner-cavity mapping oran enlarged field of view image of the surgical cavity from said lateralimages and said complementary images.

In one embodiment, the surgical cavity is visibly accessible to anexternal camera or scope aligned therewith, and said inner-cavity imagesare complementary to external images captured by said external camera orscope in enhancing inner-cavity visualization.

In one embodiment, the tool body comprises a reusable tool shaft portionand a disposable tool tip portion removably operatively connectable tosaid shaft portion, wherein said tip portion comprises said tip and saidcamera.

In accordance with another aspect, there is provided a surgical systemfor performing surgical procedures via a surgical cavity, the systemcomprising: a surgical tool comprising: a rigid elongate tool bodyhaving a substantially rigid tool tip to be displaced and tracked withinthe surgical cavity so to reproducibly locate said tool tip within thecavity; and at least one laterally-oriented camera operatively disposedalong said body at or proximal to said tip so to capture lateralinner-cavity images of the surgical cavity for output as the tool isdisplaced within the cavity, wherein said lateral inner-cavity imagesare externally communicable to associate respective lateral inner-cavityimages with tracked tool tip locations; an external tracking systemoperatively interfacing with said surgical tool to automatically track alocation of said tool tip within the cavity; and an external imageprocessing unit operable to associate a given lateral inner-cavity imagecaptured via said camera with a corresponding location of said camerawithin the cavity.

In one embodiment, the system further comprises an external imagingdevice axially aligned with the surgical cavity to capture downwardimages thereof; wherein said image processing unit is further operableto concurrently render downward images and lateral images of thesurgical cavity as the surgical tool is moved.

In one embodiment, the camera has a footprint no greater than about 2mm×2 mm, or no greater than about 1 mm×1 mm.

In one embodiment, the camera operates in a spectral region selectedfrom visible and a near infrared.

In one embodiment, the surgical cavity is at least partially defined bya surgical port.

In one embodiment, the system further comprises a set of fiducialmarkers externally coupled in a fixed configuration to an externallyextending portion of said elongate body; wherein said markers aretrackable by said external tracking system to automatically determinesaid tracked tool tip locations with reference to the cavity based on arespective tracked position of said markers.

In one embodiment, the image processing unit is further operable to mapan internal region of the surgical cavity by digitally assembling a setof said lateral images corresponding to said region and mapped theretovia each said corresponding location.

In one embodiment, the tool further comprises at least one complementarycamera disposed along said body at or proximal to said tip so to capturecomplementary images of the surgical cavity along a complementaryimaging axis angled downwardly relative to said laterally-orientedcamera so to construct a 3D inner-cavity mapping or an enlarged field ofview image of the surgical cavity from said lateral images and saidcomplementary images.

Other aspects, features and/or advantages will become more apparent uponreading the following non-restrictive description of specificembodiments thereof, given by way of example only with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

Several embodiments of the present disclosure will be provided, by wayof examples only, with reference to the appended drawings, wherein:

FIG. 1 is a diagram illustrating a perspective view of a navigationsystem, such as a medical navigation system, comprising a patientreference device, in an environmental context, such as an operationroom, in accordance with an embodiment of the present disclosure;

FIG. 2 is a schematic diagram illustrating a navigation system, such asa medical navigation system, comprising a patient reference device, inaccordance with an embodiment of the present disclosure;

FIG. 3 is a schematic diagram of a sensored surgical tool and associatedcontrol and processing unit, in accordance with an embodiment of thepresent disclosure;

FIG. 4A is a schematic cross-sectional view of a disposable tool tipportion of the sensored surgical tool of FIG. 3, in accordance with anembodiment of the present disclosure;

FIG. 4B is a schematic top plan view of the disposable tool tip portionshown in FIG. 4A;

FIG. 5 is a diagram illustrating an access port-based surgical procedurebeing conducted by way of a navigation system, in accordance with someembodiments of the present disclosure;

FIGS. 6A to 6D are perspective views of respective trackable pointingtools having distinctly configured tracking markers, in accordance withdifferent embodiments of the present disclosure;

FIGS. 6E to 6H are perspective, front elevation, side and top planviews, respectively, of a trackable surgical access port having a set oftracking markers, in accordance with an embodiment of the presentdisclosure;

FIG. 7 is a perspective view of the pointing tool of FIG. 6C, engagedwith a trackable access port, in accordance with an embodiment of thepresent disclosure;

FIG. 8 is a schematic diagram illustrating the relationship betweencomponents of a surgical navigation system, such as a control andprocessing unit, a tracking system, a data storage device for thetracking system, system devices, and medical instruments/tools, inaccordance with an embodiment of the present disclosure;

FIG. 9 is a schematic diagram illustrating a pre-operative surgicalplanning system for use with a medical navigation system, in accordancewith an embodiment of the present disclosure; and

FIG. 10 is a schematic diagram illustrating an intra-operative surgicalmanagement system for use with a medical navigation system, inaccordance with an embodiment of the present disclosure.

Elements in the several figures are illustrated for simplicity andclarity and have not necessarily been drawn to scale. For example, thedimensions of some of the elements in the figures may be emphasizedrelative to other elements for facilitating understanding of the variouspresently disclosed embodiments. Also, common, but well-understoodelements that are useful or necessary in commercially feasibleembodiment are often not depicted in order to facilitate a lessobstructed view of these various embodiments of the present disclosure.

DETAILED DESCRIPTION

The embodiments described herein provide different examples of asensored to surgical tool, and system incorporating same. The tools,systems and methods described herein may be useful in the fieldneurosurgery, including oncological care, neurodegenerative disease,stroke, brain trauma, and orthopedic surgery. However, the subjectmatter of the present disclosure may extend or apply to other conditionsor fields of medicine, and such extensions or applications areencompassed by the present disclosure. For example, the tools, systemsand methods described herein encompass surgical processes that areapplicable to surgical procedures for brain, spine, knee, and any otherregion of the body that will benefit from the use of an access port orsmall open orifice to define and access a surgical cavity within theinterior of an animal body, such as a human body.

Various tools, systems, apparatuses, devices, or processes arebelow-described and provide examples of sensored surgical tools, andsystems incorporating same, in accordance with embodiments of thepresent disclosure. None of the below-described embodiments limits anyclaimed embodiment; and any claimed embodiment may also encompass tools,systems, apparatuses, devices, or processes that may differ from thebelow-described examples. The claimed embodiments are not limited totools, systems, apparatuses, devices, or processes having all of thefeatures of any one of the below-described tools, systems, apparatuses,devices, or processes or to features common to some or all of thebelow-described tools, systems, apparatus, devices, or processes.

Furthermore, this Detailed Description sets forth numerous specificdetails in order to provide a thorough understanding of the variousembodiments described throughout the present disclosure. However, itwill be understood by those of ordinary skill in the art that theembodiments described herein may be practiced without these specificdetails. In other instances, well-known methods, procedures andcomponents have not been described in detail so as not to obscure theembodiments described herein.

With reference to FIGS. 1 and 2, and in accordance with one embodiment,an exemplary port-based surgical system incorporating a sensoredsurgical tool, will now be described. As noted above, it will beappreciated that the sensored surgical tool described herein within thecontext of a port-based surgical system and associatedtracking/navigation system, may also be amenable to other similar oralternate surgical systems and procedures, and that, without departingfrom the general scope and nature of the present disclosure. Namely, theutility and applicability of the herein-described sensored surgical toolis not limited to port-based and/or neurological procedures, but rather,may prove particularly useful and desirable in a number of surgicalenvironments in which one or more tracked surgical tools are to beoperated within a given surgical cavity where inner-cavity imagingand/or characterization is otherwise obscured or hidden from the surgeonor other medical practitioner.

In the illustrated examples, the surgical system encompasses anexemplary surgical navigation system 200 operable to track variouspatient reference devices, in an environmental context, such as anoperation room (OR). The system 200 supports, facilitates, and enhancesminimally invasive access port-based surgery using a minimally invasiveaccess port-based surgical procedure, though non port-based proceduresmay equally be considered herein as noted above.

By example only, a surgeon 101 conducts a minimally invasive access portbased surgery on a subject, such as a patient 102, in an OR environment.The navigation system 200 generally includes an equipment tower 201, arobotic arm 202 to support an external optical scope 204, and at leastone display or monitor 205, 211 for displaying a video image. By exampleonly, an operator 103 is also present to operate, control, and provideassistance for the system 200.

With particular reference to FIG. 2, the equipment tower 201 isgenerally mountable on a frame, e.g., a rack or a cart, and isconfigured to accommodate a power supply, e.g., an AC adapter powersupply, and at least one computer or controller operable by at least onea set of instructions, storable in relation to at least onenon-transitory memory device, corresponding to at least one of surgicalplanning software, navigation/tracking software, or robotic software formanaging at least one of the robotic arm 202 and at least oneinstrument, such as a surgical instrument, e.g., the access port 206,the introducer 210, and/or one or more other downstream (instrumented)surgical tools (not shown) used during the procedure. For example, thecomputer comprises at least one of a control unit and a processing unit,such as control and processing unit 400 or 1530 schematically shown inFIGS. 8 and 3, respectively. In the illustrated embodiment, theequipment tower 201 comprises a single tower configured to facilitatecoupling of the at least one display device. e.g., a primary displaydevice 211 and a secondary display device 205, with the at least onepiece of equipment. However, other configurations are also encompassedby the present disclosure, such as the equipment tower 201 comprisingdual towers configured to facilitate coupling of a single display, etc.The equipment tower 201 is also configurable to accommodate anuninterruptible power supply (UPS) for providing emergency power.

To maintain constant positioning of the patient's anatomy of interestduring a given procedure, the patient's anatomy may be held in place bya holder appropriate for the procedure in question. For example, in aport-based neurosurgical procedure, such as that illustrated in FIG. 2,a patient's head can be retained by a head holder 217. A craniotomy isperformed; and a dura flap is formed and retracted. The access port 206and introducer 210 can then be inserted into the patient's brain 102 b;and the planned procedure is executed while the patient's head remainseffectively immobile.

The system also includes a tracking system 213 that is generallyconfigured to track at least one instrument, such as a surgicalinstrument or tool. In FIGS. 1 and 2, the tracking system is initiallyutilized to track the access port 206 and introducer 210 while theaccess port is being introduced within the patient's brain so toultimately locate and define the surgical site and surrounding surgicalcavity. However, other sensored or non-sensored intra-operative surgicaltools, such as, but not limited to, inner-cavity pointing tools, suctiontools, tissue probes (e.g. Raman, OCT probes, etc.), resection tools andthe like, are also advantageously tracked by the tracking system toenhance accuracy and precision of executed operative procedures.Instrument tracking can thus significantly assist the surgeon 101 duringthe minimally invasive access port-based surgical procedure (or likeprocedures) both in guiding and confirming procedural actions, but alsoin aligning real-time surgical cavity imaging and characterization, asdetailed below within the context of tip-sensored surgical tools, withpre-operative imaging data and intra-operative external imaging (e.g.captured via external optical scope 204 and/or other cameras discussedbelow). Accordingly, tracking sensored tools such as pointing and/orsuction tools can significantly benefit enhanced or complementaryinner-cavity imaging, localization, characterization and/or mapping.

Accordingly, the tracking system 213 is configured to track anddetermine, e.g., in real-time by way of a set of instructionscorresponding to tracking software and storable in relation to at leastone non-transitory memory device, the location of the one or moretracked instruments during the surgical procedure, while also generallytracking a position of the robotic arm 202.

In the illustrated embodiment, the tracking system 213 generallycomprises at least one sensor (not shown) for detecting at least onefiducial marker 212 disposable in relation the one or more OR items(e.g. surgical arm 202) and/or surgical instruments (introducer 210) tobe tracked. In one example, the tracking system 213 comprises athree-dimensional (3D) optical tracking stereo camera, such as aNorthern Digital Imaging® (NDI) optical tracking stereo camera, whichcan be configured to locate reflective sphere tracking markers 212 in 3Dspace. In another example, the tracking camera 213 may be a magneticcamera, such as a field transmitter, where receiver coils are used tolocate objects in 3D space, as is also known in the art. Accordingly,location data of the mechanical arm 202, access port 206, introducer 210and its associated pointing tool, and/or other trackedinstruments/tools, may be determined by the tracking camera 213 byautomated detection of tracking markers 212 placed on these tools,wherein the 3D position and orientation of these tools can beeffectively inferred and tracked by tracking software from therespective position of the tracked markers 212.

In the illustrated embodiment of FIG. 2, the secondary display 205provides an output of the tracking camera 213, which may include, but isnot limited to, axial, sagittal and/or coronal views as part of amulti-view display, for example, and/or other views as may beappropriate, such as views oriented relative to the at least one trackedinstrument (e.g. perpendicular to a tool tip, in-plane of a tool shaft,etc.). These and other views may be considered in various single ormulti-view combinations, without departing from the general scope andnature of the present disclosure.

Still referring to FIG. 2, minimally invasive brain surgery using accessports is a recent method of performing surgery on brain tumors. In orderto introduce an access port 206 into a brain, such as the patient'sbrain 102 b, of a patient head's 102 a, an introducer, e.g., theintroducer 210, comprises an atraumatic tip disposable within the accessport 206 to facilitate positioning the access port 206 within thepatient brain 102 b. As noted above, the introducer 210 furthercomprises at least one fiducial marker 212 for facilitating tracking bythe tracking system 213. Generally, tracked tools such as introducer 210will include a plurality of fiducial markers to enhance trackability in3D space.

After the introducer 210 and the access port 206 are inserted into thebrain 102 b, the introducer 210 is removed to facilitate access to thetissue of the brain 102 b through the central opening of the access port206. However, after the introducer 210 is removed, the access port 206is no longer being tracked by the tracking system 213. However, theaccess port 206 is indirectly trackable by way of additional pointingtools (not shown) configured for identification by the navigation system200.

In the illustrated embodiment of FIG. 2, the navigation system 200further comprises a guide clamp 218 for retaining the access port 206.The guide clamp 218 is configured to optionally engage and disengage theaccess port 206, eliminating the need to remove the access port 206 fromthe patient 102. In some embodiments, the access port 206 is configuredto slide up and down within the guide clamp 218 in a closed position.The guide clamp 218 further comprises a locking mechanism (not shown),the locking mechanism being attachable or integrable in relation to theguide clamp 218, and the locking mechanism being optionally manuallyactuatable, e.g., using one hand as further below described.

The navigation system 200 further comprises an articulating arm 219,such as a small articulating arm, configured to couple with the guideclamp 218. The articulating arm 219 comprises up to six (6) degrees offreedom for facilitating positioning of the guide clamp 218. Thearticulating arm 219 is attachable at a location in relation to the headholder 217, or in relation to any other suitable patient supportstructure, to ensure, when locked in place, that the guide clamp 218 isfixed in relation to the patient's head 102 a. The articulating arm 219comprises an interface 219 a disposable in relation to the guide clamp218, wherein the interface 219 a is at least one of flexible or lockableinto place. Flexibility of the interface 219 a facilitates movability ofthe access port 206 into various positions within the brain 102 b, yetstill maintains rotatability about a fixed point.

The navigation system 200 may further or alternatively comprise aplurality of wide-field cameras, e.g., two additional wide-field cameras(not shown) being implemented with video overlay information, whereinone camera is mountable in relation to the optical scope 204 and theother camera is mountable in relation to the navigation system 213 (i.e.within the context of an electromagnetic tracking system). In the caseof the navigation system 213 comprising an optical tracking device, avideo image can be directly extracted therefrom. Video overlayinformation can then be used to enhance available intra-operativeinformation, for example, by providing an image displaying a physicalspace and confirming tracking system registration alignment and optionalcorresponding text and/or indicia, an image displaying a motion range ofthe robotic arm 202 holding the optical scope 204 and optionalcorresponding text and/or indicia, and/or an image displaying a guidehead positioning and a patient positioning and optional correspondingtext and/or indicia.

Other image overlays, as will be described in greater detail below, mayfurther include intraoperative cavity imaging and/or characterizationdata (e.g. colour mapping, partial image transparency overlay, textand/or indicia), such as provided by a sensored tool, (i.e. as shown inFIGS. 3, 4A and 4B), for example including, but not limited to,real-time inner cavity images (e.g. visible, near infrared (IR), etc.)provided by tool tip mounted camera(s), real-time inner cavity pressurereadings (e.g. localized fluid pressure readings, pressure gradients,pressure mappings, etc.) provided by tool tip mounted pressure sensor(s)and/or sensor arrays, and other such readings of interest given theapplication at hand. Using such real-time intraoperative inner cavityimaging and characterization data may not only enhance otherintraoperative images, such as those rendered by overhead scopes and/orcameras, but also seamlessly integrate with pre-operative images and/ordata, for instance, acquired pre-operatively using one more imagingtechniques. Accordingly, the surgeon and/or other surgical equipmentoperator can execute procedures and/or actions with greater clarity,certainty and visibility, thus leading to improved outcomes and riskreduction.

With reference to FIG. 5, a diagram of an access port-based surgicalprocedure conducted by way of the navigation system 200 is illustrated,in accordance with some embodiments of the present disclosure. In thisexample, a surgeon 501 is resecting a tumor from the brain of a patient502 through an access port 504. An external scope 505 is coupled with arobotic arm 504, and is used to view down port 504 at a sufficientmagnification to allow for enhanced visibility down port 504. The outputof external scope 505 is rendered on a visual display.

As introduced above, the procedure illustrated in FIG. 5 may involvedisposing active or passive fiduciary markers, respectively, 507, 508,e.g., spherical markers, in relation to at least one of the access port504 or the external scope 505 for facilitating their tracking (locationof these tools) by the tracking system (e.g. tracking system 213 of FIG.2). The active or passive fiduciary markers, 507, 508, are sensed bysensors of the tracking system 213, whereby identifiable points areprovided. A tracked instrument is typically indicated by sensing agrouping of active or passive fiduciary markers, 507, 508, whereby arigid body, such as a tool, is identified by the tracking system 213,and whereby the position and orientation in 3D of a tracked instrument,such as a tool, is determinable. Namely, a substantially rigid tool canbe tracked in 3D space to effectively locate and orient the tool and itsvarious segments and constituent components, provided suchsegments/components are previously defined and stored against thetracked tool type. Accordingly, a tracked tool may invoke not onlygeneral tracking, but also tracking, for example, of the tool's tip orbody, and any sensors, as will be detailed below, that may beoperatively coupled thereto in a designated configuration (e.g. at ornear a tool tip, angled relative to a tool tip or shaft, displacedand/or angled relative to other tool-mounted sensors, etc.). Typically,a minimum of three active or passive fiduciary markers, 507, 508, areplaced on a tracked tool to define the instrument. In the severalfigures included herewith, four active or passive fiduciary markers,507, 508, are used to track each tool, by example only.

In one particular example, the fiduciary markers comprise reflectospheremarkers in combination with an optical tracking system to determinespatial positioning of the surgical instruments within the operatingfield. The spatial position of automated mechanical arm(s) or roboticarm(s) used during surgery may also be tracked in a similar manner.Differentiation of the types of tools and targets and theircorresponding virtual geometrically accurate volumes can be determinedby the specific orientation of the reflectospheres relative to oneanother giving each virtual object an individual identity within thenavigation system. The individual identifiers can relay information tothe system as to the size and virtual shape of the tool within thesystem. The identifier can also provide information such as the tool'scentral point, the tools' central axis, the tool's tip, etc. The virtualtool may also be determinable from a database of tools provided to thenavigation system 200. The marker positions can be tracked relative toan object in the operating room such as the patient. Other types ofmarkers that can be used may include, but are not limited to, radiofrequency (RF), electromagnetic (EM), pulsed and un-pulsedlight-emitting diodes (LED), glass spheres, reflective stickers, uniquestructures and patterns, wherein the RF and EM would have specificsignatures for the specific tools to which they would be attached. Thereflective stickers, structures, and patterns, glass spheres, LEDs couldall be detected using optical detectors, while RF and EM could bedetected using antennas. Advantages to using EM and RF tags may includeremoval of the line of sight condition during the operation, where usingthe optical system removes the additional noise from electrical emissionand detection systems.

In a further embodiment, printed or 3D design markers can be used fordetection by an auxiliary camera and/or external scope. The printedmarkers can also be used as a calibration pattern to provide distanceinformation (3D) to the optical detector. These identification markersmay include designs such as concentric circles with different ringspacing, and/or different types of bar codes. Furthermore, in additionto using markers, the contours of known objects (e.g., side of the port,top ring of the port, shaft of pointer tool, etc.) can be maderecognizable by the optical imaging devices through the tracking system213. Similarly, or in addition thereto, structural information relatingto each tool (size, dimensions, distance and geometric orientationrelative to markers) may be used to extrapolate the position andorientation various tool segments, such as the tool tip, and varioussensors that may be operatively mounted thereon or associated therewith,as noted above.

As will be appreciated by the skilled artisan, while the above lists anumber of tracking techniques and related marker types, other known andfuture techniques may also be considered within the present context tosupport and enhance operation of the tracked surgical tools, i.e.sensored tools, described herein. Namely, the tracking technique foreach instrument will generally allow for the tracking of theinstrument's position and orientation within a given frame of reference,in which the position and orientation can be tracked, relayed and/orrendered on the surgical system's one or more displays to visuallylocate the tool, or data/images acquired thereby, within the context ofthe procedure taking place and/or any otherwise available pre-operativeand/or intraoperative images/details.

With reference to FIG. 6A, and in accordance with one illustrativeembodiment, a perspective view of an exemplary surgical tool 601 isprovided, wherein the tool 601 comprises a rigid pointer or pointingtool 600 rigidly coupled to a set of tracking markers 610 fixedlydisposed relative thereto in a designated configuration geometry that isrecognizable by the tracking system (e.g. tracking system 213 of FIG.2). In this example, the markers 610 are fixedly coupled to the pointingtool 600 via respective connector beams 615 attached to respectivelaterally extending arms 620 forming a box-like configuration in a planeof the tool's handle 625.

FIG. 6B, provides another example of a tracked surgical tool 602, againdefined by a pointer or pointing tool 640 and related tracking markers610, this time rigidly coupled to the pointing tool 640 via a laterallysplayed support arm structure 642.

Likewise, FIG. 6C provides another example of a tracked surgical tool603, again defined by a pointer or pointing tool 650 and relatedtracking markers 610, this time rigidly coupled to the pointing tool 650via an intersecting support arm structure 652.

FIG. 6D provides yet another example of a tracked surgical tool 604,again defined by a pointer or pointing tool 660 and related trackingmarkers 610, this time rigidly coupled to the pointing tool 660 via aT-shaped support arm structure 662.

In each of the examples shown by FIGS. 6A to 6D, the tracked toolincludes a pointing tool, though other surgical instruments may also beconsidered within the present context to provide a like effect. Forinstance, a suction or resection tool, or other surgical probe, may alsobe considered in which tracking is effectively provided by appropriatemarkers and a tracking system, and whereby a position and orientation ofthe tracked tool may be adequately tracked, relayed and rendered duringthe procedure. As detailed further below, the further instrumentation ofthe surgical tool (i.e. sensored tool tip), be it a pointing or othertool, to acquire inner-cavity data and/or images, as considered herein,may also apply to enhance real-time intraoperative data/imagingresources.

For completeness, and with reference to FIGS. 6E to 6H, other surgicaldevices may also be intraoperatively tracked, as noted above. Forexample, these figures respectively provide perspective, frontelevation, side and top plan views of a surgical port 680 rigidlyassociated with a corresponding set of markers 610 coupled thereto via asupport structure 682. The illustrated arrangement enables clearvisibility of the fiducial or tracking markers 610 to the trackingsystem 213, while ensuring that the markers 610 do not interfere withsurgical tools that may be inserted through the access port 680. Thenon-uniform structure of the extended arm 682 for the markers 610enables the tracking system 213 to discern both the position andorientation of the access port 680 in response to instructionscorresponding to the tracking software, for example.

With reference to FIG. 7, and in accordance with one embodiment, thetracked tool 603 of FIG. 6C is shown engaged with a tracked access port690, whereby the tracking markers 610 rigidly associated with thepointing tool 650 via support structure 652 are automaticallydiscernable by the tracking/navigation system from the tracking markers692 rigidly associated with the access port 690 via distinct supportstructure 694. Accordingly, the pointing tool 650 and access port 690are separately trackable by the tracking system 213 of the navigationsystem 200 and are differentiable as unique objects in images renderedon the display device 205.

As noted above, by mapping each instrument's position and orientation,the tracking system (e.g. system 213 of FIG. 2) may also generallyextrapolate a location and orientation of the instrument's varioussegments, such as an instrument's tip for example, when located and usedwithin the surgical cavity (i.e. down-port location and orientation inthe context of a port based procedure). Accordingly, by instrumentingthe tip or other segment of a trackable tool, instrumentation-related(sensor) data may also be dynamically associated with the trackedposition and orientation of the tool (i.e. tool tip), and effectivelymapped in relation thereto even when the tool tip location is obscuredto the external viewer/scope. Therefore, a tracked sensored tool, e.g.tool tip, may provide real-time intraoperative visibility otherwiseunavailable using pre-operative imaging and intraoperative externalscope or camera view angles. Using video and image overlays, asintroduced above, tracked tool tip instrumentation may furtheraccentuate available intraoperative data by enhancing real-time dataavailable during the procedure, which is otherwise unavailable using anexternal scope and cameras.

For example, a tracked sensored tool tip may be enhanced via thedisposition of one or more cameras (e.g. miniature camera with a microlens) at the tool tip to provide real-time intraoperative inner-cavityor down-port (within the context of a port-based procedure) images. Forexample, such down-port or inner-cavity real-time visible intraoperativeimaging may allow for the real-time capture of otherwise obscured orchallenging inner-cavity views.

Alternatively, or in combination therewith, the tracked tool tip may besensored with one or more sensors (e.g. micro-sensors) such as apressure sensor or the like to capture distinct or further inner-cavityor down-port characterizations otherwise unavailable. For example, atracked displaceable down-port or inner-cavity pressure sensor may allowfor the effective location of an obscured bleeding site, for example,which can then be more effectively addressed (e.g. via bipolar or othermethod) as compared to current methods, which generally require a blindor mostly obscured visual extra-cavity assessment. These examples willbe expanded on further below, with reference to specific embodiments.

With reference to FIG. 3, and in accordance with one embodiment, asensored surgical tool, generally referred to using the numeral 1500,will now be described. In this embodiment, the tool 1500 generallycomprises a rigid elongate tool body 1502 having a substantially rigidtool tip 1504, in this embodiment the tip 1504 forming part of adetachable/disposable sensored tool tip portion 1506 operatively coupledpartway up the tool body 1502, i.e. to a tool shaft or rod 1503. Thetool shaft 1503 integrally leads to a tool body handle 1508 and trackingportion, such as tracking marker tree 1510 encompassing a set ofconfigurationally and recognizably predisposed tracking markers 1512(i.e. fiducial markers), such as those previously discussed with respectto the examples of FIGS. 6A to 6D.

For instance, the tool's tracking marker tree 1510 may include a set oftracking markers 1512 rigidly mounted in a distinctly recognizablegeometric configuration via a designated support structure (e.g. aninstrument-specific marker configuration and/or type for automated tooltype recognition and comprehensive real-time tracking/display). Thevarious tracking techniques, marker types and configurations describedabove are equally applicable in this example.

The tool's body handle 1508 may be configured and adapted for itsintended use, be it for manual operation or again for guided orautomated operation by a robotic arm or the like, that is, amenable foroperative coupling to a robotic arm coupler, grip or clasp, as the casemay be. In this particular example, the body handle 1508 and trackingportion 1510 are shaped and oriented relative to the tool body shaft1503 and tip portion 1506 so to remain visible to the tracking system(i.e. optical tracking system 213 of FIG. 2) and related overheadcamera(s), while limiting a potential obstruction thereof to theexternal scope and/or cameras (e.g. so not to overly obstruct asurgeon's external overhead view angles. These and other trackingportion configurations, as illustrated for example in FIGS. 6A-6D, maybe considered, as will be readily appreciated by the skilled artisan.

With added reference to FIGS. 4A and 4B, the detachable/disposable tipportion 1506 comprises one or more tool tip sensors, in this embodiment,consisting of one or more imaging sensors such as cameras 1516 and/orone or more pressure sensors 1518 or like pressure-sensitivetransducers, for example. Each camera and/or sensor is operativelymounted at or near the tip 1504 to capture inner-cavity images and/ormeasurements, respectively, which can be relayed in real-time, in thisembodiment, via respective embedded wiring 1520 and correspondingcontacts 1521 (e.g. quick connect contact points) operatively disposedon the detachable tip portion 1506 to cooperate with correspondingcontacts (not shown) and wiring on the reusable tool body shaft 1503(FIG. 3). Different types of contacts 1521 may be considered, such aspressure-fitting or magnetized contacts, or again touch contact spotssolidly connected via a cooperative engagement or coupling linking theremovable tip portion 1506 and tool body shaft 1503 (e.g. snap coupling,pressure-fitted coupling, mating engagement fitting, etc.). These andother contact and component coupling techniques may be readily appliedwithin the context of the illustrated embodiment without departing fromthe general scope and nature of the present disclosure. Likewise, whiledistinct “four-channel” contacts are illustrated to communicatively linkthe various tool tip sensors to the RF transmitter via respectivewiring, different signaling configurations may also be considered, suchas joint cabling and connector configurations, and multiplexing datachanneling configurations relying, at least in part, on tip-based datapreprocessing and communication hardware, to name one example.

While not explicitly illustrated herein, appropriate power can also bedelivered to the sensors, as appropriate, to operate same. Likewise, anappropriate illumination source, such as a miniature LED light source orthe like, may be directly mounted at, near or in relation to the tip, orthe illumination thereof relayed thereto via an appropriate waveguide orfiber, as needed, and as will be readily appreciated by the skilledartisan, to provide appropriate illumination for image capture if suchillumination is not sufficiently available from external illuminationsources.

Referring to FIG. 3, in the illustrated embodiment, the embedded wiringis routed to a wireless communication device, for instance comprising aradio frequency (RF) antenna 1522 and RF circuitry 1524 operable torelay data signals produced by the tip sensor(s) 1516/1518 to acorresponding RF receiver and antenna 1526 associated with a (wireless)input/output (I/O) device & interface 1527 and related communicationinterface(s) 1528 of the surgical system's control and processing unit1530, or a subcomponent or module thereof, for example.

For instance, sensor data signals can be processed (i.e. via processor1532 and memory 1534 of the processing unit 1530) in conjunction withthe system's tracking/navigation system 1536 and related imageprocessing and display functions (i.e. schematically depicted as displaysubmodule 1538) in real-time for display alone or in combination withone or more other procedure-related visualizations (e.g. pre-operativeand/or intraoperative image overlays, pressure data mappings and/orlocalizations, etc.). Tool tip inner-cavity imaging and/or pressurecharacterizations may be externally communicated via the illustratedwiring 1520 and RF communication hardware 1524/1522, or again via otherdirect or indirect communication means, such as via one or moreelectrical, optical and/or wireless data relays, and the like, embeddedor otherwise operatively coupled to the sensored tool 1500.

With particular reference to FIG. 4A, the detachable tool tip portion1506 comprises a rigid (i.e. metal or plastic) sheath 1542 within whichthe sensor wiring 1520 may be embedded or relayed, and which forms thesurface of the tip 1504 that interfaces with the patient's inner-cavity(e.g. down-port) tissues/fluids. Embedded within, on and/or through thissheath 1542 toward the tip 1504, i.e. on or at least partly embeddedwithin or through a laterally, or mostly laterally oriented surface ofthe sheath tip portion 1506 at or toward the tip 1504, are located thecamera(s) 1516 and/or pressure sensor(s) 1518 in operative connectionwith their respective wiring 1520.

With particular reference to FIG. 4A, and in accordance with oneexemplary embodiment, the tip portion 1506 includes two cameras 1516juxtaposed lengthwise along and toward the tip 1504 such that the cameraclosest to the tip 1504 is angled (A) longitudinally/downwardly (i.e.toward a cavity bottom in operation) relative to the camera farthestfrom the tip 1504. This configuration allows, in some examples, fordistinct inner cavity intraoperative view angles that can, whenprocessed, provide different down-cavity view points to enhancevisibility and a visual explorative imaging capacity of the sensoredtool 1500 (FIG. 3), and/or be combined to construct or contribute to theconstruction of a 3D intraoperative down-cavity image. For example, oneof the cameras may be particularly oriented to capture surgical cavitysidewall images, whereas the other seeks to predominantly capture cavitybottom views. In some examples, images captured from respective tipcameras can be stitched together to enlarge a field of view of thecavity sidewall. In different embodiments, the two cameras may bejuxtaposed side-by-side, on opposite sides of the tip 1504, or consistof a single tip camera, to name a few examples.

With particular reference to FIG. 4B, the tip portion 1506 furtherincludes at least one, and in this case two pressure sensors 1518, onedisposed on either side of the longitudinally disposed cameras 1516.Again, distinct pressure readings may be used to provide distinctlylocalized pressure readings, combined to provide an average readingcorresponding to a general location of the tip 1504, or used and/orprocessed in different combinations, such as to compute real-timelocalized pressure gradients and/or variations, to name a few examples.A pressure sensor array may also be used to further enhance pressurereading versatility. As for the images relayed from the cameras 1516,pressure readings may also be used to pinpoint localized pressurereadings of interest (e.g. anomalously high pressure readings, such ascorresponding to a bleeding site or the like, sharp pressure gradientsleading to anomalous down-cavity issues, again such as a bleeding site,etc.), or again generate a localized down-cavity pressure mapping, withsuch results ultimately displayable alone or in concert with otherpre-operative and/or intraoperative images, readings and/ormeasurements. Again, while two pressure sensors 1518 are shown in thisembodiment, a single pressure sensor or a plurality of pressure sensorsin varying configurations may be used to enhance pressure readings andsensory data complexity. For example, in one embodiment, a pressuresensor array can be used to more accurately map pressure variationswithin the cavity and thus more readily pinpoint a bleeding site (e.g.from a vein or artery hole), for example, or other anomalous pressurepoint.

Various cameras may be amenable for use within the present contextprovided they have a sufficiently small footprint to accommodate thesize and area available at the tool tip 1504. For example, acomplementary metal oxide semiconductor (CMOS) camera with an integratedmicro lens may be particularly amenable for use in the present contextto generate high-resolution inner cavity images. For example, theminimal form factor image sensor NanEye 2D by Awaiba™(http://www.cmosis.com/products/product_detail/naneye) provides oneexample of a system on a chip camera having a footprint of approximately1×1 mm². For a tool tip portion diameter in the range of 4 to 5 mm, acamera footprint of this order may be suitable, even when combining twocameras and two pressure sensors in the same tip area. Clearly, where asingle camera is used, a larger footprint, for example in the range of2×2 mm² or higher may also be suitable.

Furthermore, each of the one or more cameras may consist ofself-contained camera units, thus comprising any and all circuitry toimplement the camera and capture images (e.g. pixelated/digital images)therewith, as well as any necessary optics (e.g. micro lens) integrallyformed therewith. In other embodiments, additional components, such asexternal lenses or the like, may be provided, for example within thesheath illustrated herein, or again, as an add-on component, to providea desired imaging effect. Generally, the camera(s) will be sealed in awaterproof configuration to ensure proper operation within the surgicalenvironment and reduce the likelihood of camera failures. Likewise,while identical though distinctly oriented cameras are shown in theillustrated embodiments, different camera characteristics may beconsidered to provide complementary effects (e.g. narrow vs. wide anglelens, different image spectrum sensitivity such as narrow band vs.broadband and/or visible vs. near infrared cameras, etc.). Furthermore,while not explicitly illustrated in the embodiments of FIGS. 3, 4A and4B, the sensored tip may further include, as noted above, an integratedillumination device, such as a miniature LED light source or the like toprovide required or complementary (i.e. complementary to externalillumination) inner-cavity illumination for effective image capture. Inyet another example, the tool may further include a directional lightsource such as a laser light source to gauge a distance to the imaged orcharacterized tissue by measuring reflected laser light travel times,for example.

Likewise, different pressure sensor technologies may be invoked toprovide an appropriate tool tip sensor. For example, differentfabry-perot, piezoresistive, nanotube and/or opticalmicroelectromechanical (MEMS) pressure sensors may be amenable to theherein-described application. Examples of such sensors are respectivelydescribed by G. C. Hill, et al. 2007, SU-8 MEMS Fabry-perot pressuresensor, Sensors and actuators A 138(2007) 52-62; Jialin Yao, et al.,2016, A flexible and highly sensitive piezoresistive pressure sensorbased on micropatterned films coated with carbon nanotubes, Journal ofNanomaterials, Volume 2016; and Yixian Ge, et al., An optical MEMSpressure sensor based on a phase demodulation method, Sensors andactuators A 143(2008) 224-229; the entire contents of each of which arehereby incorporated herein by reference. Other pressure sensor types mayalso be considered, without departing from the general scope and natureof the present disclosure.

As noted above, other surgical tools may be effectively sensored andtracked by the surgical system's tracking hardware to provide enhancedinner cavity characterization and/or imaging. For example, a suctiontool may be commonly used when the surgical cavity is immersed in bloodor fluid in order to seek out a bleeding or leaking site to beaddressed. Accordingly, such suction tool may be advantageously fittedwith one or more cameras and/or pressure sensors, as noted above, toimprove inner cavity assessment while using the tracked suction tool.Much like the pointing tool described above with reference to FIGS. 3,4A and 4B, the suction tool may encompass a sensored tip, i.e. laterallyoriented sensors operatively mounted on an axially or opposing laterallydirected suction tool. Alternatively, the suction tool may be combinedwith a distinct pointing tool portion, much as described above, toprovide dual functions. Such as described above, a suction tool tipportion may consist of a disposable tip portion that may be replaced foreach new procedure. As will be appreciated by the skilled artisan, othersurgical tools may equally benefit from sensor borne tool tips asdescribed above, not only to improved inner cavityimaging/characterization intraoperatively, but also to acceleratecertain surgical site processes by accurately imaging, locating andmapping inner cavity characteristics to be addressed or considered inreal-time during the surgical procedure.

With reference back to FIG. 3, the illustrative control and processingunit 1530, which may consist of a standalone or subcomponent of anoverall surgical system processing and control unit, may include, but isnot limited to comprising one or more processors 1532 (for example, aCPU/microprocessor or a graphical processing unit, or a combination of acentral processing unit or graphical processing unit), bus 1544, memory1534, which may include random access memory (RAM) and/or read onlymemory (ROM), one or more internal storage devices 1546 (e.g. a harddisk drive, compact disk drive or internal flash memory), a power supply1548, one more communications interfaces 1528, optional external storage1550, display image/data processing 1538, and one or more input/outputdevices and/or interfaces 1527 (e.g., a wireless receiver/transmitterand antenna 1526, a speaker, a display (i.e. one or more displays 205,211 of FIG. 2 and/or a linked graphical user interface (GUI) or thelike), an imaging sensor, such as those used in a digital still cameraor digital video camera, a clock, an output port, a user input device,such as a keyboard, a keypad, a mouse, a position tracked stylus, a footswitch, and/or a microphone for capturing speech commands).

Control and processing unit 1530 may be programmed with programs,subroutines, applications or modules, which include executableinstructions, which when executed by the processor, causes the system toperform one or more methods described in the disclosure. Suchinstructions may be stored, for example, in memory 1534 and/or internalstorage 1546. In particular, in the exemplary embodiment shown, imageprocessing module 1538 includes computer executable instructions foranalyzing output tool tip sensor data (images and/or pressure readings).For example, computer readable instructions may be provided forprocessing image and/or pressure data obtained at different inner-cavityspatial locations and tool tip orientations in order toimage/characterize otherwise potentially obscured regions of thesurgical cavity. The spatial location/orientation may be correlated withthe recorded image/pressure data via the tracking of the position andorientation of tool 1500, for instance tracked via illustrated trackingand navigation module 1536. For example, the tracking and navigationmodule 1536 may include executable instructions for processing trackingdata, and/or for rendering a navigation user interface on a display, asdiscussed above.

Although only one of each unit component is illustrated in FIG. 3, anynumber of each component can be included in the control and processingunit 1530. For example, a computer typically contains a number ofdifferent data storage media. Furthermore, although bus 1544 is depictedas a single connection between all of the components, it will beappreciated that the bus 1544 may represent one or more circuits,devices or communication channels which link two or more of thecomponents. For example, in personal computers, bus 1544 often includesor is a motherboard. Control and processing unit 1530 may include manymore or less components than those shown. It is also noted that one ormore external subsystems, such as a tool tip sensor data processingdevice, may be distinctly implemented and communicatively linked to anoverall surgical system control and processing unit, or form an integralpart thereof.

In one embodiment, control and processing unit 1530 may be, or include,a general purpose computer or any other hardware equivalents. Controland processing unit 1530 may also be implemented as one or more physicaldevices that are coupled to processor 1532 through one of morecommunications channels or interfaces. For example, control andprocessing unit 1530 can be implemented using application specificintegrated circuits (ASICs). Alternatively, control and processing unit1530 can be implemented as a combination of hardware and software, wherethe software is loaded into the processor from the memory or over anetwork connection.

With reference to FIG. 8, and in accordance with one embodiment,relationships between components of an overall surgical navigationsystem 200, such as a control and processing unit 400, a tracking system213, a data storage device 442 for the tracking system 213, and systemdevices 420, and medical instruments 460, will now be described. Thecontrol and processing unit 400 comprises at least one processor 402, amemory 404, such as a non-transitory memory device, a system bus 406, atleast one input/output interface 408, a communications interface 410,and storage device 412. The control and processing unit 400, which mayencompass or interface with control and processing unit 1530 of FIG. 3,is interfaced with other external devices, such as the tracking system213, data storage 442 for the tracking system 213, and external userinput and output devices 444, optionally comprising, for example, atleast one of a display device, such as display devices 211, 205, akeyboard, a mouse, a foot pedal, a microphone, and a speaker.

The data storage 442 comprises any suitable data storage device, such asa local or remote computing device, e.g. a computer, hard drive, digitalmedia device, or server, having a database stored thereon. The datastorage device 442 includes identification data 450 for identifying atleast one medical instrument 460 and configuration data 452 forassociating customized configuration parameters with at least onemedical instrument 460. The data storage device 442 further comprises atleast one of preoperative image data 454 and medical procedure planningdata 456. Although data storage device 442 is shown as a single device,understood is that, in other embodiments, the data storage device 442comprises multiple storage devices. The data storage device 442 is alsoconfigured to store data in a custom data structure corresponding tovarious 3D volumes at different resolutions, wherein each may becaptured with a unique time-stamp and/or quality metric. This customdata structure provides the system 200 (FIGS. 1 and 2) with an abilityto move through contrast, scale, and time during the surgical procedure.

Medical instruments (tools) 460 are identifiable by the control andprocessing unit 400, wherein the medical instruments 460 are coupledwith, and controlled by, the control and processing unit 400.Alternatively, the medical instruments 460 are operable or otherwiseindependently employable without the control and processing unit 400.The tracking system 213 may be employed to track at least one of themedical instruments 460 and spatially register the at least one medicalinstrument 460 in relation to an intra-operative reference frame. Asnoted above, the tracking system 213 may thus furnish the requisiteposition, orientation and location data to associate sensored tool datawith corresponding locations within the surgical cavity.

The control and processing unit 400 is also interfaceable with a numberof configurable devices, and may intra-operatively reconfigure at leastone such device based on configuration parameters obtained fromconfiguration data 452. Examples of devices 420 include, but are notlimited to, at least one external imaging device 422, at least oneillumination device 424, robotic arm 202, at least one projection device428, and at least one display device, such as display devices 211, 205.

The control and processing unit 400 is operable by the at least oneprocessor 402 and the at least one memory 404. For example, thefunctionalities described herein are at least partially implemented viahardware logic in processor 402 by way of the instructions stored inmemory 404 though at least one processing engine 470. Examples ofprocessing engines 470 include, but are not limited to, user interfaceengine 472, tracking engine 474, motor controller 476, image processingengine 478, image registration engine 480, procedure planning engine482, navigation engine 484, and context analysis module 486. Understoodis that the system 200 (FIGS. 1 and 2) is not intended to be limited tothe components shown in the several figures of the Drawing. One or morecomponents of the control and processing 400 may be provided as anexternal component or device. In one alternative embodiment, navigationmodule 484 may be provided as an external navigation system that isintegrated with control and processing unit 400.

Embodiments of the system 200 of FIG. 2 may be implemented usingprocessor 402 without additional instructions stored in memory 404.Embodiments may also be implemented using the instructions stored in thememory 404 for execution by one or more general purpose microprocessors.

Thus, the disclosure is not limited to a specific configuration ofhardware, firmware, and/or software. While some embodiments can beimplemented in fully functioning computers and computer systems, variousembodiments are capable of being distributed as a computing product in avariety of forms and are capable of being applied regardless of theparticular type of machine or computer readable media used to actuallyeffect the distribution. At least some aspects disclosed can beembodied, at least in part, in software. That is, the techniques may becarried out in a computer system or other data processing system inresponse to its processor, such as a microprocessor, executing sequencesof instructions contained in a memory, such as ROM, volatile RAM,non-volatile memory, cache or a remote storage device. A computerreadable storage medium can be used to store software and data whichwhen executed by a data processing system causes the system to performvarious methods. The executable software and data may be stored invarious places including for example ROM, volatile RAM, nonvolatilememory and/or cache. Portions of this software and/or data may be storedin any one of these storage devices.

The preceding exemplary embodiments involve systems and methods in whicha device is intra-operatively configured based on the identification ofa medical instrument. In other example embodiments, one or more devicesmay be automatically controlled and/or configured by determining one ormore context measures associated with a medical procedure. A “contextmeasure”, as used herein, refers to an identifier, data element,parameter or other form of information that pertains to the currentstate of a medical procedure. In one example, a context measure maydescribe, identify, or be associated with, the current phase or step ofthe medical procedure. In another example, a context measure mayidentity the medical procedure, or the type of medical procedure, thatis being performed. In another example, a context measure may identifythe presence of a tissue type during a medical procedure. In anotherexample, a context measure may identify the presence of one or morefluids, such as biological fluids or non-biological fluids (e.g. washfluids) during the medical procedure, and may further identify the typeof fluid. Each of these examples relate to the image-basedidentification of information pertaining to the context of the medicalprocedure.

Examples of computer-readable storage media include, but are not limitedto, recordable and non-recordable type media such as volatile andnon-volatile memory devices, ROM, RAM, flash memory devices, floppy andother removable disks, magnetic disk storage media, optical storagemedia (e.g., compact discs (CDs), digital versatile disks (DVDs), etc.),among others. The instructions can be embodied in digital and analogcommunication links for electrical, optical, acoustical or other formsof propagated signals, such as carrier waves, infrared signals, digitalsignals, and the like. The storage medium may be the internet cloud, ora computer readable storage medium such as a disc.

At least some of the methods described herein are capable of beingdistributed in a computer program product comprising a computer readablemedium that bears computer usable instructions for execution by one ormore processors, to perform aspects of the methods described. The mediummay be provided in various forms such as, but not limited to, one ormore diskettes, compact disks, tapes, chips, USB keys, external harddrives, wire-line transmissions, satellite transmissions, internettransmissions or downloads, magnetic and electronic storage media,digital and analog signals, and the like. The computer useableinstructions may also be in various forms, including compiled andnon-compiled code.

With reference to FIG. 9, a schematic diagram is provided to illustratea pre-operative surgical planning system 900 for use with a navigationsystem 200, in accordance with an embodiment of the present disclosure.The pre-operative surgical planning system 900 comprises components andinputs for planning and scoring surgical paths.

With reference to FIG. 10, a schematic diagram is provided to illustratean intraoperative surgical management system 1000 for use with anavigation system 200, in accordance with an embodiment of the presentdisclosure. The intraoperative surgical management system 1000 comprisescomponents and inputs for navigation along the surgical paths producedby the pre-operative surgical planning system 900, as shown in FIG. 9.The intra-operative surgical management system 1000 can be used as asurgical planning and navigation tool in the pre-operative andintra-operative stages. Data input(s) of the surgical planning steps andsurgical procedures, as shown in FIG. 9, can be used as input(s) to theintra-operative navigation stage performable by the intra-operativesurgical management system 1000.

The intra-operative surgical management system 1000 of the navigationsystem 200 provides a user, such as a surgeon, with a unified techniquefor navigating through a surgical region by utilizing pre-operative datainput(s) and updated intra-operative data input(s). The processor(s),such as the at least one processor 402, is operable by way of a set ofinstructions and/or algorithms storable in relation to a non-transitorymemory device, such as the at least one memory 404, wherein the at leastone processor 402 is configured to: analyze pre-operative data input(s)and intra-operative data input(s) and update surgical plans during thecourse of surgery accordingly.

For example, if intra-operative input(s) in the form of newly acquiredimages identified a previously unknown or unidentified nerve bundle or apreviously unknown or unidentified fiber track, the at least oneprocessor 402 can use these intra-operative input(s), if desired, forupdating the surgical plan during surgery to avoid contacting the nervebundle. The intra-operative input(s) may include a variety of input(s),including local data gathered using a variety of sensor(s), such as atleast one intra-operative imaging sensor (not shown). In someembodiments, the intra-operative surgical management system 1000 of thenavigation system 200 may provide continuously updated, e.g., inreal-time, intra-operative input(s) in the context of a specificsurgical procedure by way of the at least one intra-operative imagingsensor to: validate tissue position, update tissue imaging after tumorresection, and update surgical device position during surgery.

Still referring to FIG. 10, the intra-operative surgical managementsystem 1000 of the navigation system 200 may provide for re-formattingof the image, for example, to warn of possible puncture of, or collisionwith, critical tissue structures with a surgical tool during surgery. Inaddition, the intra-operative surgical management system 1000 mayprovide imaging and input updates for any shifts or surgical errors thatmight occur from a needle deflection, tissue deflection, or patientmovement as well as provide analysis and transformation of data tocorrect for imaging distortions, e.g., in real-time. The magnitude ofthese combined shifts or surgical errors is clinically significant andmay regularly exceed 2 cm. Some of the most significant distortions aremagnetic resonance imaging (MRI) based distortions such as gradientnon-linearity, susceptibility shifts, and eddy current artifacts, whichmay exceed 1 cm on standard MRI scanners (1.5 T and 3.0 T systems). Theintra-operative surgical management system 1000 mitigates, and mayeliminate, these combined shifts or surgical errors.

In accordance with some embodiments of the present disclosure, by usingthe a intra-operative surgical management system 1000, a variety ofintra-operative imaging techniques may be implemented to generateintra-operative input(s) by way of a variety of imaging devices,including anatomy specific MRI devices, surface array MRI scans,endo-nasal MRI devices, anatomy specific ultrasound (US) scans,endo-nasal US scans, anatomy specific computerized tomography (CT) orpositron emission tomography (PET) scans, port-based or probe basedphoto-acoustic imaging, sensored tool imaging and/or characterization,as well as optical imaging done with remote scanning, or probe basedscanning, whereby multi-modal imaging and data are providable andtransformable into useful images and data in real-time.

While the present disclosure describes various embodiments forillustrative purposes, such description is not intended to be limited tosuch embodiments. On the contrary, the applicant's teachings describedand illustrated herein encompass various alternatives, modifications,and equivalents, without departing from the embodiments, the generalscope of which is defined in the appended claims. Except to the extentnecessary or inherent in the processes themselves, no particular orderto steps or stages of methods or processes described in this disclosureis intended or implied. In many cases the order of process steps may bevaried without changing the purpose, effect, or import of the methodsdescribed.

Information as herein shown and described in detail is fully capable ofattaining the above-described object of the present disclosure, thepresently preferred embodiment of the present disclosure, and is, thus,representative of the subject matter which is broadly contemplated bythe present disclosure. The scope of the present disclosure fullyencompasses other embodiments which may become apparent to those skilledin the art, and is to be limited, accordingly, by nothing other than theappended claims, wherein any reference to an element being made in thesingular is not intended to mean “one and only one” unless explicitly sostated, but rather “one or more.” All structural and functionalequivalents to the elements of the above-described preferred embodimentand additional embodiments as regarded by those of ordinary skill in theart are hereby expressly incorporated by reference and are intended tobe encompassed by the present claims. Moreover, no requirement existsfor a system or method to address each and every problem sought to beresolved by the present disclosure, for such to be encompassed by thepresent claims. Furthermore, no element, component, or method step inthe present disclosure is intended to be dedicated to the publicregardless of whether the element, component, or method step isexplicitly recited in the claims. However, that various changes andmodifications in form, material, work-piece, and fabrication materialdetail may be made, without departing from the spirit and scope of thepresent disclosure, as set forth in the appended claims, as may beapparent to those of ordinary skill in the art, are also encompassed bythe disclosure.

What is claimed is:
 1. A surgical tool for use within an open surgicalcavity, the surgical tool comprising: a rigid elongate tool body havinga substantially rigid tool tip to be displaced and tracked within theopen surgical cavity to reproducibly locate said substantially rigidtool tip within the open surgical cavity; a pressure sensor operativelydisposed along said rigid elongate tool body at a position, in one of atthe substantially rigid tool tip and proximate said substantially rigidtool tip, the pressure sensor responsive to pressure variations appliedthereto from within the open surgical cavity to output a sensor signalrepresentative thereof as the substantially rigid tool tip is displacedwithin the open surgical cavity, said sensor signal externallycommunicable to associate respective inner-cavity pressure readings withlocations of the substantially rigid tool tip, and the pressure sensorcomprising at least one of: a Fabry-Perot pressure sensor, apiezoresistive pressure sensor, nanotube pressure sensor, and an opticalmicroelectromechanical (MEMS) pressure sensor; at least one cameradisposed, and laterally-oriented, along said rigid elongate tool body inone of at the substantially rigid tool tip and proximate saidsubstantially rigid tool tip to capture lateral images from within theopen surgical cavity, said lateral images externally communicable tofurther associate respective inner-cavity images with said locations ofthe substantially rigid tool tip, and the at least one camera operablein a near-infrared wavelength range; a suction tool configured tooperate with another pressure sensor and another at least one camera,the suction tool comprising a suction tool tip portion, the suction tooltip portion comprising a disposable tip portion, wherein imaging,locating, and mapping inner cavity characteristics are considered by anexternal data processing unit in real-time during a surgical procedure;and the external data processing unit operable to associate a givenpressure reading associated with the sensor signal with a correspondinglocation of the pressure sensor and with a sensor signal from the otherpressure sensor within the open externally accessible surgical cavity,said external data processing unit further operable to associaterespective inner-cavity images with locations of the substantially rigidtool tip and the location of the suction tool tip portion.
 2. Thesurgical tool of claim 1, wherein said pressure sensor is laterallyoriented relative to said substantially rigid tool tip.
 3. The surgicaltool of claim 2, wherein said pressure sensor comprises a plurality ofpressure sensors disposed at a position in one of: at the substantiallyrigid tool tip and proximate said substantially rigid tool tip.
 4. Thesurgical tool of claim 1, further comprising: a set of fiducial markersexternally coupled in a fixed configuration to an externally extendingportion of said rigid elongate tool body, wherein said markers aretrackable by an external tracking system to automatically determine saidlocations of the substantially rigid tool tip, with reference to theopen surgical cavity, based on a respective tracked position of saidmarkers.
 5. The surgical tool of claim 1, further comprising a radiofrequency transmitter to wirelessly communicate said sensor signal. 6.The surgical tool of claim 1, wherein said pressure sensor comprises aplurality of pressure sensors collocated at a position in one of: at thesubstantially rigid tool tip and toward said substantially rigid tooltip.
 7. The surgical tool of claim 1, wherein the suction tool isdisposed at a position, in one of: at the substantially rigid tool tipand proximate said substantially rigid tool tip, to concurrently providesuction within the surgical cavity around said substantially rigid tooltip.
 8. The surgical tool of claim 1, wherein an external camera isconfigured to align with, and view, the open surgical cavity, andwherein said substantially rigid tool tip is operable as a trackablepointer within the open surgical cavity.
 9. The surgical tool of claim1, further comprising at least one complementary camera disposed alongsaid rigid elongate tool body at a position, in one of at thesubstantially rigid tool tip and proximate said substantially rigid tooltip, to capture complementary images of the open surgical cavity along acomplementary imaging axis angled toward a cavity bottom relative tosaid laterally-oriented camera to construct one of a 3D inner-cavitymapping and an enlarged field of view image of the open surgical cavityfrom said lateral images and said complementary images.
 10. The surgicaltool of claim 9, wherein at least one of an external camera and a scopeis configured to align with, and view, the open surgical cavity, andwherein said inner-cavity images are complementary to external imagescaptured by at least one of the external camera and the scope inenhancing inner-cavity visualization.
 11. The surgical tool of claim 1,wherein said substantially rigid tool tip is movable within the opensurgical cavity to track pressure variations resulting from inner-cavitybleeding in locating a bleeding site within the open surgical cavity.12. The surgical tool of claim 1, wherein said rigid elongate tool bodycomprises a reusable tool shaft portion and a disposable tool tipportion removably operatively connectable to said shaft portion, andwherein said disposable tool tip portion comprises said substantiallyrigid tool tip and said pressure sensor.
 13. A surgical system forperforming surgery through an open externally accessible surgicalcavity, the system comprising: a surgical tool, the surgical toolcomprising: a rigid elongate tool body having a substantially rigid tooltip to be displaced and tracked within the open externally accessiblesurgical cavity to reproducibly locate said substantially rigid tool tipwithin the open externally accessible surgical cavity; a pressure sensoroperatively disposed along said rigid elongate tool body at a position,in one of at the substantially rigid tool tip and proximate saidsubstantially rigid tool tip, the pressure sensor responsive to pressurevariations applied thereto from within the open externally accessiblesurgical cavity to output a sensor signal representative thereof as thesubstantially rigid tool tip is displaced within the open externallyaccessible cavity, and the pressure sensor comprising at least one of: aFabry-Perot pressure sensor, a piezoresistive pressure sensor, nanotubepressure sensor, and an optical microelectromechanical (MEMS) pressuresensor; at least one camera disposed, and laterally-oriented, along saidrigid elongate tool body in one of at the substantially rigid tool tipand proximate said substantially rigid tool tip to capture lateralimages from within the open externally accessible surgical cavity, theat least one camera operable in a near-infrared wavelength range; asuction tool configured to operate with another pressure sensor andanother at least one camera, the suction tool comprising a suction tooltip portion, the suction tool tip portion comprising a disposable tipportion, wherein imaging, locating, and mapping inner cavitycharacteristics are considered by an external data processing unit inreal-time during a surgical procedure; an external tracking systemoperatively interfacing with said surgical tool and the suction tool toautomatically track a location of said substantially rigid tool tip anda location of the suction tool tip portion within the open externallyaccessible surgical cavity; and the external data processing unitoperable to associate a given pressure reading associated with saidsensor signal with a corresponding location of said pressure sensor andwith a sensor signal from the other pressure sensor within the openexternally accessible surgical cavity, said external data processingunit further operable to associate respective inner-cavity images withlocations of the substantially rigid tool tip and the location of thesuction tool tip portion.
 14. The surgical system of claim 13, whereinsaid surgical tool further comprises a set of fiducial markersexternally coupled, in a fixed configuration, with an externallyextending portion of said rigid elongate tool body, and wherein saidmarkers are trackable by an external surgical navigation system toautomatically associate said corresponding location of said pressuresensor within the open externally accessible surgical cavity based on arespectively tracked position of said markers.
 15. The surgical systemof claim 13, wherein said pressure sensor is laterally oriented relativeto said substantially rigid tool tip.
 16. A surgical tool for use withinan open externally visible surgical cavity that is visibly accessible toone of an external camera and a scope aligned therewith, the surgicaltool comprising: a rigid elongate tool body having a substantially rigidtool tip to be displaced and tracked within the open externally visiblesurgical cavity so as to reproducibly locate said substantially rigidtool tip within the open externally visible surgical cavity; at leastone laterally-oriented camera operatively disposed along said rigidelongate tool body at a position, in one of at the substantially rigidtool tip and proximate said substantially rigid tool tip, to capturelateral inner-cavity images of the open externally visible surgicalcavity for output as the substantially rigid tool tip is displacedwithin the open externally visible surgical cavity, said lateralinner-cavity images externally communicable to associate respectivelateral inner-cavity images with locations of the substantially rigidtool tip, said inner-cavity images complementary to external imagescaptured by one of said external camera and the scope in enhancinginner-cavity visualization, and the at least one laterally-orientedcamera operable in a near-infrared wavelength range; and a suction toolconfigured to operate with a pressure sensor, another pressure sensor,at least one camera, and another at least one camera, the suction toolcomprising a suction tool tip portion, the suction tool tip portioncomprising a disposable tip portion, wherein imaging, locating, andmapping inner cavity characteristics are considered by an external dataprocessing unit in real-time during a surgical procedure, and thepressure sensor comprising at least one of: a Fabry-Perot pressuresensor, a piezoresistive pressure sensor, nanotube pressure sensor, andan optical microelectromechanical (MEMS) pressure sensor; and theexternal data processing unit operable to associate a given pressurereading associated with said sensor signal with a corresponding locationof said pressure sensor and with a sensor signal from the other pressuresensor within the open externally accessible surgical cavity, saidexternal data processing unit further operable to associate respectiveinner-cavity images with locations of the substantially rigid tool tipand the location of the suction tool tip portion.
 17. The surgical toolof claim 16, further comprising a set of fiducial markers externallycoupled, in a fixed configuration, with an externally extending portionof said rigid elongate tool body, wherein said set of fiducial markersis trackable by an external tracking system to automatically determinelocations of the substantially rigid tool tip, with reference to thecavity, based on a respective tracked position of said markers.
 18. Thesurgical tool of claim 16, further comprising a radio frequencytransmitter to wirelessly communicate said lateral inner-cavity images.19. The surgical tool of claim 16, wherein the suction tool is disposedat a position, in one of at the substantially rigid tool tip andproximate said substantially rigid tool tip, to concurrently providesuction within the open externally visible surgical cavity around saidsubstantially rigid tool tip.
 20. The surgical tool of claim 16, furthercomprising at least one complementary camera disposed along said rigidelongate tool body at a position, in one of at the substantially rigidtool tip and proximate said substantially rigid tool tip, to capturecomplementary images of the open externally visible surgical cavityalong a complementary imaging axis angled toward a cavity bottomrelative to said laterally-oriented camera to construct one of a 3Dinner-cavity mapping and an enlarged field of view image of the openexternally visible surgical cavity from said lateral images and saidcomplementary images.